Cleared Traditional

K061770 - ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM

K061770 is an FDA 510(k) clearance for ETHICON ENDO SURGERY ENDOSCOPIC SUTURIN..., manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K061770 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
94d
Days
Class 2
Risk

K061770 is an FDA 510(k) clearance for the ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 25, 2006 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061770

510(k) Number K061770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2006
Decision Date September 25, 2006
Days to Decision 94 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 131d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCW Device Classification - Class 2, Special Controls

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 69
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K061770.
MINI LAP INSTRUMENTS
K070686 · Mini Lap Technologies, Inc. · Apr 2007
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
K062875 · Endogastric Solutions, Inc. · Mar 2007
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · Arthrocare Corp. · Oct 2006
SMARTSTITCH M-CONNECTOR, MODEL OM-8700
K033317 · Opus Medical, Inc. · Dec 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · Ethicon Endo-Surgery, Inc. · Dec 2003
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
K030170 · Opus Medical, Inc. · Jul 2003
K061770 · ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
Download PDF FDA Summary Ethicon Endo-Surgery,…